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- Sartopore® 2 | 0.2 µm | Capsule (PD | Scale Up)
Sartopore® 2 | Capsule | 0.2µm | Size 4 | 5pc.
Designed for scale-up in the PD area, Sartopore® 2 Capsules provide seamless transition from development to production. Their versatile design supports various applications, ensuring consistent performance and reliability.
- Item No.:
- 5441307H4--OO--B
- Pieces
- 5
Designed for scale-up in the PD area, Sartopore® 2 Capsules provide seamless transition from development to production. Their versatile design supports various applications, ensuring consistent performance and reliability.
Overview
Specifications
Choose your Sartopore® 2
Sartopore® 2: Sterilizing-Grade Filters
Sartopore® 2 0.2 µm Sterilizing-Grade Filter Elements are the industry standard for high-performance liquid sterile filtration. With a unique hydrophilic heterogeneous double-layer design, these filters offer exceptionally high throughput and excellent flow rates, making them ideal for a wide range of applications.
Key Features
- Hydrophilic Double Layer Design: Features a 0.45 μm pre-filter and a 0.2 μm final filter membrane, ensuring high throughput and flow rate. This design enhances filtration efficiency, reducing processing time and costs.
- Polyethersulfone Membrane: Provides broad chemical compatibility, including a pH range from 1 to 14, and high thermal resistance. This ensures reliable performance across various chemical environments.
- Validated Sterilizing Grade: Fully validated according to ASTM F-838 guidelines, each filter element undergoes integrity testing, ensuring absolute reliability and compliance with regulatory standards.
- Scalability: Available in a wide range of sizes and formats, from 4.5 cm² up to 1.8 m² per filter element, allowing for seamless scale-up from R&D to full-scale production.
Applications
Typical applications include bioburden and particle removal of
- Therapeutics
- Biological Fluids
- Ophthalmic solutions
- Injectables
- Media
- SVPs and LVPs
- Antibiotics
- WFI
- Buffers
- Chemicals
- Cleaning and sanitizing agents
- Bulk pharmaceutical products
Benefits
- High Throughput: The unique membrane design allows for high flow rates at low pressure drops, optimizing processing efficiency.
- PFAS restrictions: Made without intentionally using PFAS compounds to ensure you are prepared for potential future restrictions.
- Broad Compatibility: The Polyethersulfone membrane ensures compatibility with a wide range of chemicals, enhancing versatility in application.
- Reliability and Compliance: Each filter is integrity tested and meets stringent regulatory standards, providing peace of mind and assurance in critical applications.
Sartopore® 2 filters are designed to meet the demanding needs of the pharmaceutical and biotechnology industries, offering unparalleled performance and reliability.
Applications
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ApplicationHigh capacity platform for conventional sterile filtration
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IndustryPharma / Biotech
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ModalityBuffer & Auxiliaries Filtration
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ScaleProduct Development | Scale Up Filters
Biological Information
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Bacterial RetentionQuantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology
Compliance Information
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Bacterial Endotoxins< 0.25 EU/mL as determined by the LAL test
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Biological ReactivityAll materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).
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ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Connections (Physical)
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Connector Inlet1/4" Multiple Stepped Hose Barb
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Connector Outlet1/4" Multiple Stepped Hose Barb
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Connector(s)Inlet: ¼" Hose Barb | Outlet: ¼" Hose Barb
Dimensions
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Filter Sizesize 4 (0.015 m² / 0.16 ft²)
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Filtration Area0.015 m²
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Outer Diameter63 mm (46 mm without Connection / Valves)
General Specifications
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Capsule/Cartridge FormatCapsules
-
Maximum Allowable Back Pressure
-
2 bar (29 psi) at 20°C
- 1.5 bar (21.8 psi) at 50°C
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2 bar (29 psi) at 20°C
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Maximum Diffusion1 mL/min at 2.5 bar | 36 psi at 20 °C
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Minimum Required Bubble Point3.2 bar | 46 psi
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Vent ValveStandard
Materials of Construction
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Housing MaterialPolypropylene (PP)
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Material o-ring | sealSilicone (SI)
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Membrane MaterialPolyethersulfone (PES)
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Support FleecePolypropylene (PP)
Operating Conditions
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Maximum Differential Pressure20 °C: 4 bar, 50 °C: 3 bar
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Maximum Operating Pressure4 bar (58 psi)
Physicochemical Information
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Non-Fiber ReleasingThis filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
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Pore Size Final-filter0.2 µm
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Pore Size Pre-filter0.45 µm
Product Information
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BrandSartopore® 2
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Pack Size5
Sterility/Purity
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Delivery ConditionSterile - Autoclaved
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Sterilization MethodAutoclavable
Usage Protocols
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Sterilization ProceduresAutoclaving: at 134°C, 30 min, 2 bar, min. 5 Cycles